The FDA is investigating the safety of the abortion drug mifepristone, which could allow the Trump administration to impose restrictions on its use, The Wall Street Journal reported.
The FDA investigation is likely to conclude by the end of the year and comes as President Trump faces harsh criticism from anti-abortion activists for failing to use his executive powers to restrict access to the pill, according to the Journal.
Mifepristone, which was used in 63% of abortions in the United States in 2023, according to the Guttmacher Institute, has been on the market in the United States for more than a quarter of a century and has been repeatedly declared safe by the FDA.
In a Q&A posted on its website, the FDA said it was conducting safety studies on mifepristone as of April of this year.
“The next steps in the mifepristone safety study are to conduct data exploration, data integrity assessment, analysis, validation, and peer review,” the report said, adding that the study is expected to be completed within a year.
In previous studies, such as last year’s review of coronavirus mRNA vaccines, the agency used information from the FDA Adverse Event Reporting System (FAERS) drug safety database.
The anti-abortion movement suffered a blow last month when the U.S. Supreme Court blocked a federal appeals court ruling in Louisiana. The ruling would have prohibited mifepristone from being prescribed over the phone or mailed throughout the United States. The new ruling allows access to mifepristone via telemedicine to remain in place while the case plays out in lower courts.
Last month, Christy Hamrick, a lobbyist for Students for Life of America, told Politico that “our patience has reached its limit.”
“The pro-life movement, like many other parts of the (Republican) coalition, invested in Donald Trump. We want to see a return on that investment,” she added.
Pro-life advocates argue that mifepristone (used in combination with the labor-inducing drug misoprostol to terminate pregnancies up to the first 10 weeks) can cause bleeding.
Pro-choice advocates, meanwhile, say they are using safety as a last resort to limit drug availability.
“The telemedicine ban on mifepristone was never about safety. It was about controlling people’s bodies and lives,” Angel Foster, co-founder of the Massachusetts Medical Abortion Access Project, said in a statement last month after the SCOTUS decision.
In 2021, the FDA lifted the requirement to receive mifepristone in person during the coronavirus pandemic.
In April 2023, the Louisiana Fifth Circuit Court of Appeals moved to ban the mailing of pills and limit mifepristone use during pregnancy from 10 weeks to 7 weeks. The ruling matched the Supreme Court’s 2022 decision overturning the landmark Roe v. Wade case.
In a court brief preceding the SCOTUS decision, nine former FDA chiefs said the appellate court’s approach “undermines FDA’s gold standard science-based drug approval system” and warned that the decision “creates a roadmap for attacks on science-based drug regulatory decisions.”
Mifepristone was developed in France and approved in France in 1988. The FDA approved approval of this drug in 2000. Mifepristone works by blocking the hormone progesterone, which is necessary for a pregnancy to continue.
